A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
研究概览
简要总结
This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems
排除标准
- •The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
- •history or evidence of age-related macular degeneration on baseline evaluation
- •history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
- •history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
- •history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
- •history or evidence of glaucoma on baseline evaluation
- •history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
- •evidence of center foveal thickness of >190 µm on baseline OCT examination
- •presence of vacuoles in the retina on baseline OCT
研究组 & 干预措施
Vorapaxar
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
干预措施: Vorapaxar 2.5 mg (Drug)
Placebo
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
时间窗: Up to 12 months
Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).
次要结局
- Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT(Baseline and 4, 8 and 12 months)
- Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline(Baseline and 4, 8 and 12 months)
- Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT(Baseline and 4, 8 and 12 months)
- Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography(Baseline and 4, 8 and 12 months)